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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameTECHSTAR AND TECHSTAR XL 6 FRENCH PERCUTANEOUS VASCULAR SURGICAL SYSTEMS
ApplicantABBOTT VASCULAR INC.
PMA NumberP960043
Supplement NumberS010
Date Received08/03/1998
Decision Date12/21/1998
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to expand the range of users of the prostar(r) and techstar(r) pvs systems to inlcude healthcare professionals other than physicians.
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